What this study is
The study proposes to develop a phenylephrine protocol to be used during transesophageal echocardiography, whereby intravenous phenylephrine would be used to increase afterload with the intent to mimic the awake hemodynamic profile and variation that occurs with normal physical activity. The expectation is to see changes in severity of Mitral Regurgitation (MR) grade with increasing afterload, which in turn can provide more accurate quantification of MR severity to assist in clinical decision making.
What's being tested
- Mydfrin
Intervention · DRUG
A test dose of 20 mcg of Mydfrin will be administered through the peripheral intravenous line. BP will be monitored after each bolus of phenylephrine. Subsequent Mydfrin injections will then be administered in 50 mcg aliquots every 10-15 minutes, instead of 40 mcg, until the mean arterial blood pressure (MAP) increases by ≥ 20 mm Hg from the baseline MAP, however making sure not to exceed a MAP of 100 mmHg. Once a desired blood pressure has been achieved and maintained, echocardiographic evaluation of mitral regurgitation would be performed.
Study details
- Official title
- Evaluating the Severity of Mitral Regurgitation Using Phenylephrine During Transesophageal Echocardiography
- Sponsor
- Montefiore Medical Center
- Conditions
- Mitral Regurgitation
- Enrolling
- 35 people
- Starts
- 2020-12-01
- Est. completion
- 2026-06
- Design
- Open-label, single group, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Patients 18 years or older with MR on baseline echocardiographic evaluation who are scheduled to undergo TEE for further evaluation of mitral regurgitation.
You can't join if
- Patients who are not clinically eligible for TEE.
- Patients with contraindications to esophageal intubation.
- Patients with hemodynamic instability.
- Patients with acute decompensated heart failure (HF).
- Patients with un-revascularized severe coronary artery disease (triple vessel or left main disease).
- Patients with ongoing unstable angina or ongoing myocardial infarction (MI)
- Patients with significant arrhythmias including atrial fibrillation.
- Patients with uncontrolled hypertension (BP ≥ 150/90 mmHg).
- Patients with preexisting bradycardia (HR < 50) and heart blocks.
- Patients with severe symptomatic peripheral vascular disease.
- Patients with severe pulmonary hypertension (estimated systolic pulmonary arterial pressure sPAP ≥ 60mm Hg).
- Patients who are at high risk for intracranial bleeding such as patients with previous strokes, transient ischemic attack (TIA) and vascular malformations.
- Additionally, patients with mean arterial blood pressure MAP > 100 mmHg during TEE and those with severe MR, effective regurgitant orifice area (ERO > 39cm2) on baseline TEE evaluation will not be given phenylephrine and excluded from the study.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMontefiore Medical Center
New York, New York, United States
- Mario Garcia, MD · Contact
Recruiting
Study team
Sponsor
Montefiore Medical Center
Study ID 2020-11414
Principal investigator
Mario Garcia, MD
Montefiore Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.